LATANOPROST TEVA-RATIOPHARM 50 micrograms/ml EYE DROPS SOLUTION

2. What you need to know before you use Latanoprost Teva-ratiopharm

Latanoprost Teva-ratiopharm can be used in adult men and women (including the elderly) and in children from birth to 18 years of age. Latanoprost Teva-ratiopharm has not been studied in premature infants (less than 36 weeks gestation).

Do not use Latanoprost Teva-ratiopharm

• if you are allergic to latanoprost or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Consult your doctor or the doctor treating your child or pharmacist before starting to use Latanoprost Teva-ratiopharm or before giving it to your child if you think any of the following apply to you or your child:

• If you or your child have had or are going to have eye surgery (including cataract surgery)
• If you or your child have eye problems (such as eye pain, irritation or inflammation, blurred vision)
• If you or your child have dry eyes
• If you or your child have severe asthma or uncontrolled asthma
• If you or your child wear contact lenses. You can continue to use Latanoprost Teva-ratiopharm, but you must follow the instructions in Section 3 for contact lens wearers
• If you have had or are having a viral infection of the eye caused by the herpes simplex virus (HSV).

Using Latanoprost Teva-ratiopharm with other medicines

Latanoprost Teva-ratiopharm may interact with other medicines. Tell your doctor, the doctor treating your child or pharmacist if you or your child are taking/using, have recently taken/used or might take/use any other medicines (or eye drops), including those obtained without a prescription. In particular, tell your doctor or pharmacist if you know you are taking prostaglandins, prostaglandin analogues or prostaglandin derivatives.

Pregnancy and breastfeeding

Do not use Latanoprost Teva-ratiopharm if you are pregnant or breastfeeding.

If you are pregnant or think you may be pregnant, or if you are planning to become pregnant, consult your doctor before using this medicine.

Driving and using machines

When using Latanoprost Teva-ratiopharm, blurred vision may occur for a short time. If this happens, do not driveor use tools or machines until your vision is clear again.

Latanoprost Teva-ratiopharm contains benzalkonium chloride and phosphate buffers

This medicine contains 0.2 mg/ml of benzalkonium chloride.

Benzalkonium chloride can be absorbed by soft contact lenses and may alter the color of contact lenses. You should remove contact lenses before using this medicine and wait 15 minutes before putting them back in.

Benzalkonium chloride may cause eye irritation, especially if you have dry eyes or other diseases of the cornea (the transparent layer on the front of the eye). Consult your doctor if you feel any unusual sensation, itching or pain in the eye after using this medicine.

This medicine contains 6.43 mg/ml of phosphates.

If you have severe damage to the transparent front part of the eye (the cornea), phosphates may rarely cause cloudy areas in the cornea due to calcium deposits produced during treatment.

3. How to use Latanoprost Teva-ratiopharm

Follow exactly the instructions for administration of this medicine given by your doctor, the doctor treating your child or pharmacist. If you are unsure, consult your doctor, the doctor treating your child or pharmacist again.

The recommended dose for adults (including elderly people) and children is one drop into the affected eye(s) once daily, preferably in the evening.

Do not use latanoprost more than once a day, as the effectiveness of the treatment may decrease if it is administered more frequently.

Use latanoprost as your doctor or the doctor treating your child has told you, until they tell you to stop.

Contact lens wearers

If you or your child wear contact lenses, you must remove them before using latanoprost. After applying latanoprost, you must wait 15 minutes before putting the contact lenses back in.

Instructions for use

To administer latanoprost properly, you must follow these steps:

1. Wash your hands and sit or stand comfortably.
2. Remove the cap.
3. Gently pull down the lower eyelid of the eye to be treated.
4. Place the tip of the bottle close to the eye, but without touching it.
5. Gently squeeze the bottle so that only one drop goes into the eye. Release the lower eyelid.
6. Press the finger into the corner of the eye, near the nose, for 1 minute, keeping the eye closed.
7. Repeat the operation in the other eye, if your doctor has told you to do so.
8. Put the cap back on the bottle.

If you use Latanoprost Teva-ratiopharm with other eye drops

Wait at least 5 minutes between the application of latanoprost and the administration of other eye drops.

If you use more Latanoprost Teva-ratiopharm than you should

If you apply more drops in the eye than you should, you may feel a slight irritation in the eye and your eyes may also become red and watery. This situation should disappear, but if you are concerned, contact your doctor or the doctor treating your child.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20.

If you forget to use Latanoprost Teva-ratiopharm

Continue with the administration of the next dose as usual. Do not apply an extra drop in the eye to make up for the missed dose. If you have any doubts, consult your doctor or pharmacist.

If you stop using Latanoprost Teva-ratiopharm

If you want to stop using latanoprost, consult your doctor or the doctor treating your child.

If you have any other questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following are known side effects when using Latanoprost Teva-ratiopharm:

Very common(may affect more than 1 in 10 people):

• Gradual change in eye color due to an increase in the amount of brown pigment in the colored part of the eye known as the iris. If you have mixed-color eyes (blue-brown, gray-brown, yellow-brown or green-brown) you are more likely to experience this change than if your eyes are a single color (blue, gray, green or brown). The change in eye color takes years to develop, although it can usually be seen after 8 months of treatment. The change in eye color may be permanent and may be more noticeable if you use latanoprost in only one eye. The change in eye color does not seem to be associated with any problems. The change in eye color does not progress once treatment with latanoprost has been stopped.
• Redness of the eye.
• Eye irritation (feeling of itching, feeling of grit in the eye, itching, pain and feeling of a foreign body in the eye). If you experience severe eye irritation that makes your eyes water excessively or makes you consider stopping treatment, consult your doctor or pharmacist as soon as possible (within a week). You may need to have your treatment reviewed to ensure you are receiving the right treatment for your condition.
• Gradual change in the eyelashes of the treated eye and the fine hair around the treated eye, observed in most patients of Japanese origin. These changes include an increase in color (darkening), length, thickness and number of eyelashes.

Common(may affect up to 1 in 10 people):

• Irritation or disorders of the eye surface, inflammation of the eyelid (blepharitis), eye pain, sensitivity to light (photophobia), conjunctivitis.

Uncommon(may affect up to 1 in 100 people):

• Swelling of the eyelids, dry eyes, inflammation or irritation of the eye surface (keratitis), blurred vision, inflammation of the colored part of the eye (uveitis), swelling of the retina (macular edema).
• Skin rash.
• Chest pain (angina), feeling the heartbeat (palpitations).
• Asthma, difficulty breathing (dyspnea).
• Chest pain.
• Headache, dizziness.
• Nausea, vomiting.
• Muscle pain, joint pain.

Rare(may affect up to 1 in 1,000 people):

• Inflammation of the iris (iritis), symptoms of swelling or injury/damage to the eye surface, swelling around the eye (periorbital edema), misdirected eyelashes or extra row of eyelashes, scarring of the eye surface, accumulation of fluid in the colored part of the eye (iris cyst).
• Skin reactions on the eyelids, darkening of the eyelid skin.
• Worsening of asthma.
• Severe itching of the skin.
• Development of a viral eye infection caused by the herpes simplex virus (HSV).

Very rare(may affect up to 1 in 10,000 people):

• Worsening of angina in patients who also have heart problems.
• Appearance of sunken eyes (greater depth of the eyelid fold).

Side effects observed in children at a higher frequency than in adults are runny nose and itchy nose and fever.

In very rare cases, some patients with severe damage to the transparent front part of the eye (cornea) have developed cloudy areas in the cornea due to calcium deposits produced during treatment.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Latanoprost Teva-ratiopharm

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and bottle after EXP. The expiry date is the last day of the month shown.

Store in a refrigerator (between 2°C and 8°C).

Keep the bottle in the outer carton in order to protect from light.

After opening the bottle: Do not store above 25°C. The bottle must be discarded 4 weeks after opening, even if there is still some solution left.

Medicines should not be disposed of via wastewater or household waste. Place the empty packaging and any unused medicine in the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and any unused medicine. This will help protect the environment.

6. Contents of the pack and other information

Composition of Latanoprost Teva-ratiopharm

The active substance is latanoprost.

One ml of eye drops solution contains 50 micrograms of latanoprost.

One drop contains approximately 1.5 micrograms of latanoprost.

The other ingredients are benzalkonium chloride, sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate, sodium chloride, purified water.

Appearance and packaging

Latanoprost Teva-ratiopharm is a clear, colorless eye drops solution in a low-density polyethylene (LDPE) dropper bottle with a high-density polyethylene (HDPE) screw cap.

Each bottle contains 2.5 ml of eye drops solution, which corresponds to approximately 80 drops of solution.

Latanoprost Teva-ratiopharm is available in packs of 1 x 2.5 ml, 3 x 2.5 ml and 6 x 2.5 ml.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

Teva Pharma, S.L.U.

C/ Anabel Segura 11, Edificio Albatros B 1ª planta

28108 Alcobendas, Madrid (Spain)

Manufacturer:

Merckle GmbH

Ludwig-Merckle-Strasse 3

89143 Blaubeuren

Germany

Or

Jadran Galenski Laboratorij d.d.

Svilno 20,

51000 Rijeka

Croatia

This medicine is authorised in the Member States of the EEA under the following names:

Germany Latanoprost-ratiopharm 50 Mikrogramm/ml Augentropfen, Lösung

France Latanoprost Teva Santé 50 microgrammes/ml collyre en solution

Italy Latanoprost ratiopharm 50 microgrammi/ml collirio, soluzione

Netherlands Latanoprost 50 microgram/ml Teva, oogdruppels, oplossing

Spain Latanoprost Teva-ratiopharm 50 microgramos/ml colirio en solución

Date of last revision of this leaflet: April 2022

Other sources of information

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http: //www.aemps.gob.es/

You can access detailed and updated information about this medicine by scanning the QR code included in the packaging with your mobile phone (smartphone). You can also access this information at the following internet address: https://cima.aemps.es/cima/dochtml/p/71101/P_71101.html

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